Phase III results of Parkinson's drug formulation has insider buying up shares Print E-mail
By M.E.Garza   
Friday, 26 August 2011 00:08

Early last week, Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ:IPXL) and GlaxoSmithKline (NYSE:GSK) said that their extended-release experimental drug for Parkinson's disease had met its main goal in their Phase III study. Shares rose over 10% on the news and a day later, (on 08/16/11) Larry Hsu, President and CEO of the company purchased 10,000 shares at an average price of $19 spending a total of $190,000 along the way.

Director Leslie Benet had purchased shares prior to the published study results on 08/05/11 and 08/08/11 as shares traded between $15.71 and $17.25. Her buy totals equaled just north of $25K.
These recent buys followed some heavy selling in early June by directors Robert Burr, Michael Markbreiter, Nigel Fleming, Peter Terreri . Those sales took place shortly after company shares had dropped from the $26+ trading levels   link: http://www.secform4.com/insider-trading/1003642.htm

Is the recent heavy insider buying a hint about future events surrounding the innovative Parkinson’s drug formulation?

The recent late-stage clinical trial measured the effectiveness of IPX066, which Impax designed to be a longer-lasting version of a common treatment for the physical symptoms of Parkinson's disease. The study compared the new formulation to the standard form of the drugs carbidopa and levodopa.

The IPX066 pharmacokinetic profile offers reliable control of Parkinson's Disease symptoms, such as the reduction in "off time" throughout the day, which had been observed in preliminary studies of IPX066. "Off time" is the functional state when patients' medication effect has worn off and there is a return of Parkinson symptoms.

The the drug Impax tested against in the study, levodopa,  was introduced 4 decades ago but it remains the most effective therapy for patients with Parkinson's disease. Conventional levodopa therapy consists of the concurrent administration of levodopa with a dopa decarboxylase inhibitor (DDCI), such as carbidopa. The DDCI reduces the metabolism of levodopa before it reaches the brain, thus controlling the symptoms of Parkinson's disease with lower dosages of levodopa than possible when administered alone.

A clinical study published in the January 2005 issue of "Clinical Therapeutics" showed that more than twice as many Parkinson's disease patients prefer Parcopa(TM) (carbidopa-levodopa orally disintegrating tablets) to conventional carbidopa-levodopa tablets.

In 2006, Impax had received a non-approvable letter from the Food and Drug Administration for Vadova tablets- a formulation of the Parkinson's drug that the FDA had noted a number of deficiencies in as part of Impax’s new drug application.

Almost two years later in 2008, Impax announced that it had begun work to develop this next-generation carbidopa/levodopa product.

Impax and GlaxoSmithKline said patients treated with this “longer-lasting” drug had significantly less "off time," or waking time when their medication wore off and the motor symptoms of Parkinson's disease returned.
The study enrolled 110 subjects, with 91 subjects entering the randomized comparative phase of the study. A total of 84 subjects completed the randomized double-blind comparative phase of the study.
In three patients each, the most common side effects of treatment with IPX066 observed were insomnia, confusion, and sudden, uncontrollable muscle movements. The most common side effect of the carbidopa-levodopa regimen was falling, which affected two patients.

The BioMedReports FDA and Worldwide Regulatory Calendar shows three upcoming trade catalysts including a fourth  quarter of 2011 submission of a New Drug Application (NDA) for IPX066 to the FDA, by Impax. In addition, which is planned for the fourth quarter of 2011.

Impax also has a product for Restless Legs Syndrome (IPX159) which has completed a Phase IIa study. The calendar shows the company is planning a Phase IIb study in moderate to severe RLS patients in the near term, as well.

Their partner, GlaxoSmithKline, which is based in London, will file for approval in European Union in 2012. As part of an agreement signed during late 2010, Glaxo has full rights to develop and sell the drug in all countries except the U.S. and Taiwan. In addition, Impax is eligible to receive potential payments of up to $175 million upon successful achievement of certain development and commercialization milestones for the drug.

Impax Pharmaceuticals has two products in its development pipeline, directed to neurology as a therapeutic focus, with four other central nervous system (CNS) specific products undergoing feasibility assessment.

In the past officials at the company have said that the CNS space is ideally suited to IMPAX’s core competency in drug delivery, as so many products are candidates for improved dosing and administration and since the market was large and growing at almost 10% annually, faster than the total U.S. pharmaceutical market.

Shares of Impax stock have traded as high as $ 28.75 and as low as $ 14.46 during the past 52 weeks.

Additional presentations and data about Impax’s formulation of the Parkinson’s drug can be seen here: http://phx.corporate-ir.net/phoenix.zhtml?c=67240&p=irol-calendar

In early 2008, Solvay Pharmaceuticals-- before it was acquired Abbott Laboratories (NYSE: ABT)-- was granted fast track designation by the US Food and Drug Administration for Duodopa, the levodopa/carbidopa intestinal gel it is developing for the long-term treatment of motor fluctuations associated with advanced Parkinson's disease.

Doctors looking at the intestinal gel said that while levodopa is the mainstay of Parkinson's disease (PD) treatment, it is often eventually associated with disabling motor complications in patients with advanced forms of the disease. The inability of perorally administered levodopa to provide more physiologic continuous dopaminergic stimulation (CDS) is a leading hypothesis to explain these complications.

The aqueous gel, is continuously infused (daytime only or 24 hours) via a portable pump and tube permanently inserted into the duodenum through percutaneous endoscopic gastrostomy (PEG) and  the infusion provides stable levodopa plasma levels, which are significantly less variable than those with oral levodopa. 

According to a paper published earlier this year, the gel demonstrated efficacy in reducing levodopa-associated motor complications in patients with advanced Parkinson's disease. 

Abbott announced the interim efficacy and safety results from the study in June.



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